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NCT06828419Not yet recruiting

A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery

Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
63 (estimated)
First submitted
4 Feb 2025
Start date
10 Apr 2025
Primary completion date
31 Dec 2026
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
NCT number
NCT06828419

What you commit to

  • Study type: Interventional
  • Planned participants: 63
  • From 10 Apr 2025 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects on long-term anticoagulant therapy or with coagulation dysfunction;
  • Not willing to undergo endoscopic surgery;
  • Participated in other drug and device clinical trials within 3 months before surgery.

Other illness

  • Genital tract infection or in the acute phase of systemic infection;
  • Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot tolerate anesthesia;
  • A history of abdominal or diaphragmatic hernia, abnormal umbilical cord development, or umbilical surgery;

Other

  • Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system;
  • Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs;

Who the study is looking for

  • Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg/m2;
  • Conscious, no history of mental illness, accompanied by an adult during the perioperative period;
  • Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method;
  • Subjects and families understand perioperative care and are willing and able to complete post-discharge care;
  • Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points;
  • According to the adhesion risk scoring system of European Anti-Adhesions in Gynaecology Expert Panel (ANGEL), the adhesion risk was divided into three levels: high, medium and low. Subjects with low risk (0 to 12 points) and abdominal wall scarring and pelvic cavity B-ultrasonography do not indicate obvious pelvic cavity adhesion wiil be included.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Second Affiliated Hospital of Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.